Medical Device Labeling 2.0: End of the Pilot Program and Launch of Mandatory Labeling from June 1, 2026

16.02.2026

Russia continues to expand its digital marking system, ‘Chestny ZNAK’. The ‘Medical Device Marking 2.0’ experiment runs from 1 September 2024 to 28 February 2026, and is a preparatory stage for the launch of mandatory marking for new categories of medical devices from 1 June 2026 (as part of the updated Governmental Resolution No. 894).

For companies, this isn't just a regulatory change, it's a transformation of data management, logistics, and ERP integration processes.

What is to be changed

The list of product groups includes new categories:

  • syringes
  • infusion systems
  • medical masks
  • laboratory test tubes
  • medical and sanitary wipes
  • barrier contraception
  • therapeutic respiratory equipment
  • neonatal incubators
  • aesthetic and plastic implants.

How it will influence companies

The introduction of mandatory medical devices marking will lead to the review of companies' operational and IT processes. Business will need to ensure end-to-end product traceability, integration with ‘Chestny ZNAK’, and adaptation of ERP systems and EDI the new requirements. Companies will face additional requirements for master data management, warehouse operations, logistics, and reporting. Without timely preparation, the risk of supply disruptions, fines for non-compliance with regulatory requirements, and increased operating costs increase. At the same time, digital marking creates opportunities for increased supply chain transparency, improved inventory control, and improved management data quality.

How we can help

SCHNEIDER GROUP has practical experience implementing digital product marking solutions since the launch of the first mandatory marking projects in Russia. Our team began working with marking in 2019 as part of the implementation of footwear marking requirements and has since accumulated significant experience implementing projects across all key product groups of ‘Chestny ZNAK’.

We accompany clients through all stages of adaptation to new regulatory requirements. Our support includes:

  • Impact assessment of marking on existing business processes and IT architecture
  • Target architecture development considering complex ERP landscapes (SAP, 1C, and hybrid environments)
  • Integration assistance with ‘Chestny Znak’
  • Warehouse accounting, logistics, and document management processes automation
  • International companies support in localizing marking requirements.

Practical experience gained in marking projects for various product categories – from early initiatives to ongoing large-scale implementations – allows us to anticipate typical risks and ensure implementation with minimal impact on our clients’ operations.

Contacts:

Yuriy Krasilnikov – Associate Director, IT Business Applications, SCHNEIDER GROUP Moscow